Catalog Number

QDSW

Brand Name

Pall QPoint Docking Station Shower

Version/Model Number

QDSW

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K163609,K163609

Product Code

NHV

Product Code Name

System, Water Purification, General Medical Use

Public Device Record Key

9d91daca-b107-4d00-9567-ac9de06516f9

Public Version Date

December 05, 2019

Public Version Number

1

DI Record Publish Date

November 27, 2019

Package DI Number

35034480315602

Quantity per Package

2

Contains DI Package

05034480315601

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-